Advisor, Manufacturing Quality Assurance - Lilly Medicine Foundry

About the role

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The Foundry will combine research and manufacturing in a single location, allowing Lilly to optimize manufacturing processes, increase clinical trial medicine capacity, reduce costs, and decrease environmental impact. The initial position will be fluid and dynamic, supporting the Foundry's startup, building a new organization, and developing necessary systems and business processes for GMP operations. This role requires significant collaboration, creativity, and resilience as the site grows to a full-scale GMP manufacturing facility.

Responsibilities

• Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
• Support cross-functional teams, facilitate decision making and drive progress.
• Support the execution of the site operational readiness plan including development of early phase quality processes and operational procedures and controls.
• Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Work cross-functionally with the plant teams to develop processes, provide operational support, and issue management.
• Assist with inspection readiness activities.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate with internal and external stakeholders.
• Participate in global communities of practice and committees, as appropriate, to establish and maintain a network for benchmarking and share learning.
• Identify and lead process improvement projects impacting multiple business areas.

Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Experience in API manufacturing small and/or large molecules and/or high potent antibody drug conjugates (ADC).
• Experience with applicable equipment cleaning requirements.
• Relevant industry experience in high-paced working environments.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Preferences

• Experience in API manufacturing small and/or large molecules and/or high potent antibody drug conjugates (ADC).
• Experience with applicable equipment cleaning requirements.
• Relevant industry experience in high-paced working environments.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Additional Preferences

• Experience in API manufacturing small and/or large molecules and/or high potent antibody drug conjugates (ADC).
• Experience with applicable equipment cleaning requirements.
• Relevant industry experience in high-paced working environments.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Basic Requirements